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Table 13. Antiretroviral Therapy-Associated Common and/or Severe Adverse Effects

 (See Appendix B for additional information listed by drug.)  (Page 3 of 4)




 Adverse Effects  NRTIs  NNRTIs               PIs           INSTI                EI


 Hypersensitivity reaction  ABC:  NVP:                   RAL            MVC: reported as
 (HSR) (excluding rash  • HLA-B*5701 screening should be performed prior to  • Hypersensitivity syndrome of hepatic  part of a syndrome
 alone or Stevens  initiation of ABC and ABC should not be started if HLA-  toxicity and rash that may be  related to
 Johnson syndrome[SJS])  B*5701 is positive.  accompanied by fever, general malaise,  hepatotoxicity
 fatigue, myalgias, arthralgias, blisters,
 • Symptoms of HSR include (in descending frequency):  oral lesions, conjunctivitis, facial edema,
 fever, skin rash, malaise, nausea, headache, myalgia,
 eosinophilia, granulocytopenia,
 chills, diarrhea, vomiting, abdominal pain, dyspnea,
 lymphadenopathy, or renal dysfunction.
 arthralgia, and respiratory symptoms.
 • In ARV-naive patients, risk is greater for
 • Symptoms worsen with continuation of ABC
 women with pre-NVP CD4 count
             3
 • Median onset of reactions is 9 days; ~ 90% of reactions  >250 cells/mm and men with pre-NVP
                        3
 within first 6 weeks  CD4 count >400 cells/mm . Overall, risk
 is higher for women than men.
 • Onset of rechallenge reactions is within hours of
 rechallenge dose  • 2-week dose escalation of NVP reduces
 risk.
 • Patients, regardless of HLA-B*5701 status, should not be
 rechallenged with ABC if HSR suspected.

 Lactic acidosis  NRTIs, especially d4T, ZDV, and ddI
 • Insidious onset with GI prodrome, weight loss, and
 fatigue. May be rapidly progressive, with tachycardia,
 tachypnea, jaundice, muscular weakness, mental status
 changes, respiratory distress, pancreatitis, and organ
 failure.

 • Mortality up to 50% in some case series, especially in
 patients with serum lactate >10 mmol/L

 • Females and obese patients at increased risk.

 Laboratory findings:
 • ↑ lactate (often >5 mmol/L), anion gap, AST, ALT, PT,
 bilirubin

 • ↑ amylase and lipase in patients with pancreatitis

 •  arterial pH, serum bicarbonate, serum albumin








 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents                                                                                                              K-10
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